Song Pil Sang, Park Kyu Tae, Kim Min Jeong, Jeon Ki Hyun, Park Jin Sik, Choi Rak Kyeong, Song Young Bin, Choi Seung Hyuk, Choi Jin Ho, Lee Sang Hoon, Gwon Hyeon Cheol, Jeong Jin Ok, Im Eul Soon, Kim Sang Wook, Chun Woo Jung, Oh Ju Hyeon, Hahn Joo Yong
Division of Cardiology, Cardiovascular Center, Mediplex Sejong General Hospital, Incheon, Korea.
Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Korean Circ J. 2019 Jan;49(1):69-80. doi: 10.4070/kcj.2018.0097. Epub 2018 Aug 24.
There are no data comparing clinical outcomes of complex percutaneous coronary intervention (PCI) between biodegradable polymer-biolimus-eluting stents (BP-BES) and durable polymer-everolimus-eluting stents (DP-EES). We sought to evaluate the safety and efficacy of BP-BES compared with DP-EES in patients undergoing complex PCI.
Patients enrolled in the SMART-DESK registry were stratified into 2 categories based on the complexity of PCI. Complex PCI was defined as having at least one of the following features: unprotected left main lesion, ≥2 lesions treated, total stent length >40 mm, minimal stent diameter ≤2.5 mm, or bifurcation as target lesion. The primary outcome was target lesion failure (TLF), defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI), or target lesion revascularization (TLR) at 2 years of follow-up.
Of 1,999 patients, 1,145 (57.3%) underwent complex PCI: 521 patients were treated with BP-BES and 624 with DP-EES. In propensity-score matching analysis (481 pairs), the risks of TLF (3.8% vs. 5.2%, adjusted hazard ratio [HR], 0.578; 95% confidence interval [CI], 0.246-1.359; p=0.209), cardiac death (2.5% vs. 2.5%, adjusted HR, 0.787; 95% CI, 0.244-2.539; p=0.689), TV-MI (0.5% vs. 0.4%, adjusted HR, 1.128; 95% CI, 0.157-8.093; p=0.905), and TLR (1.1% vs. 2.9%, adjusted HR, 0.390; 95% CI, 0.139-1.095; p=0.074) did not differ between 2 stent groups after complex PCI.
Clinical outcomes of BP-BES were comparable to those of DP-EES at 2 years after complex PCI. Our data suggest that use of BP-BES is acceptable, even for complex PCI.
目前尚无关于生物可降解聚合物-生物雷帕霉素洗脱支架（BP-BES）与耐用聚合物-依维莫司洗脱支架（DP-EES）在复杂经皮冠状动脉介入治疗（PCI）中临床结局比较的数据。我们旨在评估在接受复杂PCI的患者中，BP-BES与DP-EES相比的安全性和有效性。
将纳入SMART-DESK注册研究的患者根据PCI的复杂性分为两类。复杂PCI定义为具有以下至少一项特征：无保护左主干病变、治疗≥2处病变、总支架长度>40 mm、最小支架直径≤2.5 mm或分叉病变作为靶病变。主要结局为靶病变失败（TLF），定义为随访2年时心源性死亡、靶血管相关心肌梗死（TV-MI）或靶病变血运重建（TLR）的复合终点。
在1999例患者中，1145例（57.3%）接受了复杂PCI：521例患者接受BP-BES治疗，624例接受DP-EES治疗。在倾向评分匹配分析（481对）中，复杂PCI后两组间TLF风险（3.8%对5.2%，调整后风险比[HR]，0.578；95%置信区间[CI]，0.246 - 1.359；p = 0.209）、心源性死亡风险（2.5%对2.5%，调整后HR，0.787；95% CI，0.244 - 2.539；p = 0.689）、TV-MI风险（0.5%对0.4%，调整后HR，1.128；95% CI，0.157 - 8.093；p = 0.905）和TLR风险（1.1%对2.9%，调整后HR，0.390；95% CI，0.139 - 1.095；p = 0.074）无差异。
复杂PCI后2年，BP-BES的临床结局与DP-EES相当。我们的数据表明，即使对于复杂PCI，使用BP-BES也是可接受的。
